On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early 2020, and gave the federal government flexibility to waive or modify certain requirements in a range of areas, including emergency use authorizations (EUAs) by the U.S. Food and Drug Administration (FDA). The FDA also reacted to the PHE by exercising enforcement discretion for premarket review and other requirements for dozens of device types, including but not limited to infusion pumps, remote monitoring devices, masks, and imaging systems. Given that the federal policies surrounding enforcement discretion are tied to the PHE, its end is expected to remove the regulatory relaxations and trigger regulatory submissions later this year.

Devices Under PHE Enforcement Discretion

Early during the PHE, the FDA acknowledged the importance of maintaining the availability of certain devices during the pandemic, also taking into consideration the impact of supply chain limitations. In response, the FDA issued several guidance documents that describe enforcement policies for certain devices that are intended to support the emergency response to the PHE.

The FDA recognized that it would take time for device manufacturers, healthcare facilities, healthcare providers, patients, consumers, and the FDA to adjust from the policies adopted and operations implemented during the PHE to someday resuming normal regulatory operations. To provide a clear policy, the FDA issued a draft guidance in 2021 to describe the FDA’s general recommendations for a phased transition process with respect to devices that fall within the enforcement policies issued during the PHE. The “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” (“Transition Guidance”) includes recommendations regarding submitting a marketing application (e.g., 510(k), De Novo, or PMA), as applicable, and taking other actions with respect to these devices.

The draft guidance for the FDA’s transition plans described a multi-phase rollout plan. The FDA proposed a transition period that begins on a currently non-specified implementation date as part of a three-phase rollout. The implementation date is expected to be at least 45 days after finalization of the draft guidance and then the enforcement discretion guidances would be withdrawn at least 180 days after the implementation date.

• Phase 1: Begins on the implementation date. If not already doing so, manufacturers should follow 21 CFR Part 803 (i.e., adverse event reporting requirements) in order to prepare for Phase 3.
• Phase 2: Begins 90 days after the implementation date. Before the start of Phase 2 and in order to prepare for Phase 3, if not already doing so, manufacturers should follow 21 CFR Part 806 (i.e., reports of corrections and removals requirements) and, if planning to continue to distribute their devices after the transition period, should also follow 21 CFR Part 807 Subparts B-D (i.e., registration and listing requirements).
• Phase 3: Begins 180 days after the implementation date. At the start of Phase 3, the FDA intends to withdraw the enforcement discretion guidances, and manufacturers will be expected to comply with all statutory and regulatory requirements applicable to their devices (e.g., 21 CFR Part 820, 21 CFR Part 801 Subpart B, and 21 CFR Part 830), subject to certain limitations. Prior to the start of Phase 3, the FDA expects any marketing submission for a device within the scope of Transition Guidance to be submitted and accepted if the manufacturer intends to continue distribution of the device after the enforcement discretion guidances are withdrawn. Where possible, the FDA strongly encourages manufacturers to work to complete such submissions well in advance of the start of Phase 3 to avoid potential delays created by a large influx of new submissions and to best serve the public health. The FDA does not intend to object to continued distribution of devices within the scope of the Transition Guidance where a marketing submission has been submitted and accepted by the FDA before the start of Phase 3 and the FDA has not taken a final action on the marketing submission.

In anticipation of the PHE ending, manufacturers should prepare their transition strategy so they can be ready to submit the applicable premarket application within the specified Transition Guidance timeline. Manufacturers should also consider whether any data gathered while operating under the respective enforcement discretion policy can be used to support their application.

Although the Transition Guidance is currently in draft form (as is a similar but not identical policy regarding EUAs), the FDA has stated that it intends to finalize those draft guidances along with several others during 2023.

Devices and Drugs Under EUA

The ending of the PHE will not impact the FDA’s ability to authorize devices (including tests), treatments, or vaccines for emergency use. Existing EUAs for products will remain in effect and the FDA may continue to issue new EUAs going forward when criteria for issuance are met. If an EUA declaration is terminated, notice of termination will be published in the Federal Register. Before an EUA declaration is terminated, the Secretary of Health and Human Services will issue a Federal Register notice providing advance notice to the public that the EUA declaration is being terminated. This would trigger the process outlined in the Transition Guidance. The FDA lists terminated and revoked EUAs here.

Contact

For questions regarding FDA strategy, submissions, and regulatory compliance, please contact any member of Wilson Sonsini’s FDA regulatory, healthcare, and consumer products practice.

Eva Yin and Mary O’Brien contributed to the preparation of this Wilson Sonsini Alert.